SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. This device is intended for males only.

Device Description

The SpeediCath Compact Set is a sterile, ready to use intermittent catheter for males. It is a single use catheter with an integrated urine bag. The catheter is a hollow tube consisting of polyurethane and methylmethacrylate-acrylonitrilebutadiene-styrene polymer [MABS]. It facilitates drainage of urine from the bladder through the urethra to the collection bag. It is available in one size FR/CH 12/18. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) containing polyethylene glycol (PEG) inside a tube. The swelling medium resides between the catheter and the tube and lubricates the catheter.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "SpeediCath Compact Set" Urological Catheter and Accessories, product number K200820, from Coloplast A/S. This document focuses on demonstrating substantial equivalence to a predicate device (SpeediCath Compact Set, K121458), rather than detailing specific acceptance criteria and a study to prove a device meets those criteria from an AI/algorithm perspective.

The document does not describe an AI/algorithm-based device and therefore does not contain information on:

Acceptance criteria for an AI algorithm's performance.
A study proving an AI device meets acceptance criteria.
Sample size used for an AI test set or its data provenance.
Number or qualifications of experts for ground truth.
Adjudication methods for an AI test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone performance of an AI algorithm.
Type of ground truth used for AI models.
Sample size for an AI training set.
How ground truth for an AI training set was established.

Instead, the document focuses on the substantial equivalence of a physical medical device (a urological catheter) based on non-clinical performance testing.

Here's a summary of the non-clinical performance testing for the SpeediCath Compact Set, as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific numerical acceptance criteria (e.g., a specific coefficient of friction value) and reported performance against those. Instead, it indicates that testing was conducted per applicable standards and that "the results were acceptable."

Test Category	Standard/Method	Reported Performance
Biocompatibility	ISO 10993-1:2018; FDA Guidance "Use of International Standard ISO 10993-1" (2016)	Acceptable
Cytotoxicity	(Included in Biocompatibility)	Acceptable
Irritation	(Included in Biocompatibility)	Acceptable
Sensitivity	(Included in Biocompatibility)	Acceptable
Chemical Characterization	(Included in Biocompatibility)	Acceptable
Coefficient of Friction	ASTM D1894:2014	Acceptable
Corrosion	EN ISO 20696:2018; EN 1616:1997	Acceptable
Shelf Life	ASTM F1980-16 (Accelerated and Real-Time aged)	Acceptable
Sterilization Dose Setting	ISO 11137-1:2015; ISO/TS 13004:2013	Acceptable
Impact of Swelling Medium Modification:
Catheter coating - finger test	Established methods	Acceptable
Catheter coating dry out in air	Established methods	Acceptable
Catheters, objective friction measurement	Established methods	Acceptable
pH of the swelling medium	Established methods	Acceptable
Osmolality of the swelling medium	Established methods	Acceptable

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided text for any of the tests.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided. The tests described are non-clinical, laboratory-based performance tests, not clinical evaluations requiring expert interpretation of ground truth in the context of an AI device.

4. Adjudication method for the test set:

This information is not applicable and not provided, as the tests are non-clinical.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable, as this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable, as this is not an AI device.

7. The type of ground truth used:

Not applicable, as the tests are non-clinical hardware performance evaluations against established physical/chemical standards, not against "ground truth" as it would be defined for an AI diagnostic or predictive model (e.g., pathology, outcomes data, expert consensus). The "ground truth" here is effectively the established engineering and biological standards.

8. The sample size for the training set:

Not applicable, as this is not an AI device.

9. How the ground truth for the training set was established:

Not applicable, as this is not an AI device.

Conclusion from document: The document concludes that "The performance testing demonstrates the subject device is as safe and as effective as the predicate device." This is the basis for the FDA's substantial equivalence determination for this physical medical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 13, 2020

Coloplast Michael Bumgarner Principal Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411

Re: K200820

Trade/Device Name: SpeediCath Compact Set Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: October 2, 2020 Received: October 5, 2020

Dear Michael Bumgarner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sharon M. Andrews Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K200820

Device Name SpeediCath Compact Set

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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SpeediCath Compact Set Traditional 510(k)

Image /page/3/Picture/1 description: The image shows the Coloplast logo with the text "K200820 Page 1 of 3" in the upper right corner. The logo consists of a blue globe-like symbol with horizontal lines and the word "Coloplast" in blue, bold letters. The text indicates that this is page 1 of a 3-page document with the identification number K200820. The overall impression is that this is a document from Coloplast, possibly related to a product or service.

510(K) SUMMARY 5.0

Submitted by:	Coloplast A/SHoltedam13050 HumlebaekDenmark
Contact Person :	Michael BumgarnerPrincipal Regulatory Affairs SpecialistColoplast1601 West River Road NorthMinneapolis, MN 55411612-263-0488usmbum@coloplast.com
Date of Summary:	13 November 2020
Trade or ProprietaryName:	SpeediCath Compact Set
Common or Usual Name:	Catheter, Urethral
Classification Name:	Urological Catheter and Accessories
Regulation Number	21 CFR 876.5130
Classification:	Class II
Product Code:	GBM (Catheter, urethral)
Review Panel:	Gastroenterology/Urology
Predicate Device:	SpeediCath Compact Set, K121458The predicate device has not been subject to a design related recall.

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SpeediCath Compact Set

Traditional 510(k)

Device Description: The SpeediCath Compact Set is a sterile, ready to use intermittent catheter for males. It is a single use catheter with an integrated urine bag. The catheter is a hollow tube consisting of polyurethane and methylmethacrylate-acrylonitrilebutadiene-styrene polymer [MABS]. It facilitates drainage of urine from the bladder through the urethra to the collection bag. It is available in one size FR/CH 12/18. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) containing polyethylene glycol (PEG) inside a tube. The swelling medium resides between the catheter and the tube and lubricates the catheter. SpeediCath Compact Set is indicated for use by patients with Indications for Use: chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. This device is intended for males only. The subject and predicate devices have the same intended use. Comparison of Technical The subject device and predicated device have different technological characteristics as follows: Characteristics: -Swelling medium in the subject contains polyethylene glycol (PEG); the predicate contains polyvinylpyrrolidone (PVP). The different technological characteristics of the subject device do not raise different questions of safety and effectiveness.

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Traditional 510(k)

Image /page/5/Picture/2 description: The image shows the Coloplast logo in blue. The text "K200820 Page 3 of 3" is located in the upper right corner of the image. The logo is a sphere with horizontal lines and the word "Coloplast" next to it.

Summary of Non-Clinical Performance Testing:

Performance testing for SpeediCath Compact Set was conducted per applicable sections of voluntary and FDA consensus standards and the results were acceptable:

. Biocompatibility testing (cytotoxicity, irritation, sensitivity, and chemical characterization) according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2016)
Coefficient of friction according to ASTM D1894:2014 ●
Corrosion according to EN ISO 20696:2018 and EN 1616 :1997
. Accelerated and Real Time aged shelf life testing according to ASTM F1980-16
Sterilization dose setting according to ISO 11137-1:2015 and ISO/TS 13004:2013

The following tests were completed using established methods to determine the impact of the swelling medium modification based upon assessment of the risk documentation and the results were acceptable:

Catheter coating - finger test
Catheter coating dry out in air ●
Catheters, objective friction measurement
pH of the swelling medium
Osmolality of the swelling medium

Conclusion: The performance testing demonstrates the subject device is as safe and as effective as the predicate device.

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.